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The multinational nature of the pharmaceutical industry and the rapid changes within global technology mean that drug development has become an expensive and lengthy process. Paediatric drug development has faced many challenges and hurdles, including the ever growing need to reduce development costs and improve clinical trial strategies for children.

Paediatric Medicine will bring you completely up-to-date on current and new developments within paediatrics, including legislation, regulation, and the issues involved in conducting clinical trials in children. The conference will answer your key questions including:

  • What are the incentives for companies to develop paediatric drugs?
  • How can you develop effective paediatric clinical trials systems?
  • What are the problems and solutions for paediatric drug delivery?
  • How do you recruit children for successful clinical trials?

Why should you attend this event?
This comprehensive conference is organised and produced by SMi: we specialise in providing senior executives with timely, strategic and focused up to date information. SMi conferences are leading-edge business events offering delegates the opportunity to meet senior industry and government figures and seek their advice and opinions. The conference will of course also be an ideal opportunity for you to network with a focused and appropriate audience.

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Dr Andrew J Rankin

Dr Andrew J Rankin, Director, Exploratory Development, Pfizer

9:10 INTRODUCTORY OVERVIEW TO DEVELOPING DRUGS FOR PAEDIATRIC MEDICINE

Dr Andrew J Rankin

Dr Andrew J Rankin, Director, Exploratory Development, Pfizer

  • Paediatric exclusivity
  • Issues surrounding paediatric clinical trials
  • Future developments
  • 9:40 SCIENTIFIC PAEDIATRIC TRIAL DESIGN

    Dr Jochen Theis

    Dr Jochen Theis, Associate Director, Adenbrookes Centre for Clinical Investigations, GlaxoSmithKline

  • Developmental pharmacokinetics
  • Developmental phamacodynamics
  • Age-Appropriate assessment methods
  • Innovative trial designs
  • 10:20 CHILDREN ARE NOT MINIATURE ADULTS

    Jonathan Rigby

    Jonathan Rigby, Head, Business Development; Europe & Japan, Profile Therapeutics

  • Problems and issues facing the delivery of pulmonary medicines in the paediatric population
  • Addressing the problems-an overview of available devices
  • Adaptive Aerosol Delivery (AAD™)- a novel approach
  • Clinical benefits of AAD in children
  • 11:00 Morning Coffee

    11:20 RESPIRATORY DELIVERY TO PAEDIATRICS

    Dr Paul Wright

    Dr Paul Wright, Associate Director, Product Development, AstraZeneca

  • Age differences
  • Clinical guidelines
  • Device choice; MDI, DPI or nebuliser
  • Monitoring
  • 12:00 FORMULATION ISSUES

    Dr Ronald Coffee

    Dr Ronald Coffee, Chairman & Chief Executive Officer, Electrosols

  • Use of electric field energy to produce and deliver new dosage formulations
  • Oral dosage formulations with ultra-fast dispersion
  • Monodispersed electro-aerosols for inhalation
  • Charged droplets for accurate, user-friendly topical applications
  • 12:40 Networking Lunch

    14:00 PAEDIATRIC DRUG DEVELOPMENT

    Dr Klaus Rose

    Dr Klaus Rose, Senior International Medical Advisor, Novartis Pharma AG

  • Global clinical development only in adults no longer possible
  • Adapt company mindset about scope and role of paediatric issues
  • Mobilise knowledge resources across clinical project teams
  • Focus communication across line functions on paediatric issues
  • Use best existing services, encourage development of new ones
  • 14:40 COMPASSIONATE (PRIOR LICENCE) USE OF MEDICINES IN PAEDIATRICS

    Dr Irja Lutsar

    Dr Irja Lutsar, Associate Director, Pfizer

  • Ethical issues
  • Different Regulatory issues in the EU
  • Data collection and using this data for filing
  • 15:20 Afternoon Tea

    15:40 EXPLOITING E-TECHNOLOGIES TO ENHANCE INVESTIGATOR COMMUNICATION AND ACCELERATE STUDY DELIVERY

    Martin Young

    Martin Young, Commercial Operations Director, Phase Forward Europe

  • Increasing the effectiveness of prestudy activities and site initiation
  • Exploiting information access and availiability during study and conduct
  • Building valued communities amoungst sites and enhancing communication with sponsor staff
  • Practical experiences and learnings from international studies in 55 countries
  • 16:20 PAEDIATRIC PHARMACOKINETICS

    Dr Beverley Patterson

    Dr Beverley Patterson, Senior Pharmacokineticist, Eli Lilly

  • Conventional and population methods for evaluating pharmacokinetics
  • Intrinsic and extrinsic factors influencing pharmacokinetics and therapeutic outcome
  • Regulatory aspects with particular focus on labelling
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Dr Alan Davies

    Dr Alan Davies, Therapeutic Director, Kendle

    9:10 CONSTRUCTING CLINICAL TRIALS SUCCESSFULLY IN CHILDREN

    Dr Alan Davies

    Dr Alan Davies, Therapeutic Director, Kendle

  • Understanding the needs and expectations of patients in trials
  • The advantages of non-invasive testing
  • Trial design
  • Improving paediatric patient recruitment
  • Assessing compliance in clinical trials
  • Implications for the future
  • 9:40 SETTING THE SCENE FOR PAEDIATRIC CLINICAL TRIALS

    Dr Sue Ablett

    Dr Sue Ablett, Executive Director, UK Children’s Cancer Study Group (UKCCSG)

  • What are the key issues?
  • Practical considerations
  • Ethical issues
  • Maintaining regulatory compliance
  • The gold standard of paediatric licensing
  • 10:20 DEVELOPING AN EFFECTIVE SYSTEM

    Dr Vas Novelli

    Dr Vas Novelli, Consultant in Paediatric Infectious Diseases, Great Ormond Street Hospital for Children

  • Highlight the specific challenges of paediatric trial work
  • Overcoming the obstacles to recruiting patients for specific therapy areas
  • Funding/Cost of conducting the trial
  • Ethics Committee approval
  • Measuring outcomes
  • Putting into practice
  • 11:00 Morning Coffee

    11:20 SUCCESS AND PITFALLS OF PAEDIATRIC CLINICAL TRIALS

    Dr Michael Christensen

    Dr Michael Christensen, Associate Professor of Pharmacy & Paediatrics, University of Tennessee

  • Successes and pitfalls of exclusivity
  • Successes of the Network of paediatric pharmacology research units
  • Success and pitfalls of protocol design from the perspective of a clinical research site
  • Need for changes for the success of paediatric clinical trials
  • 12:00 IMPACT OF STUDY DESIGN ON RECRUITMENT FOR PAEDIATRIC TRIALS

    Dr Mark Schreiner

    Dr Mark Schreiner, Executive Medical Director, Children’s Clinical Research Institute

  • Importance of the clinical question
  • Ensuring a scientifically sound design
  • Minimising risks and procedures and maximising benefits (if any)
  • Feasibility within a busy clinician’s practice
  • Feasibility for a busy family and child
  • 12:40 Networking Lunch

    14:00 CRITICAL BARRIERS TO THE SUCCESSFUL PAEDIATRIC CLINICAL TRIAL

    Dr Ross McKinney Jr

    Dr Ross McKinney Jr, Associate Professor, Duke University Medical Center

  • Why too many paediatric trials fail to meet expectations
  • Keys to the design of a successful paediatric trial
  • Finding the patients
  • 14:40 REGULATION ISSUES

    Dr Richard Tiner

    Dr Richard Tiner, Medical Director, ABPI

  • Assessing the global regulatory climate for paediatric drug trials
  • Envisaging the future in developing therapies for children in relation to legislation
  • The paediatric Rule
  • Update on ICH Guidelines
  • Current situation in UK and Europe
  • 15:20 Afternoon Tea

    15:40 LEGAL ISSUES

    Diana Sternfeld

    Diana Sternfeld, Partner, Willoughby & Partners

  • The law’s view of clinical trials
  • Data protection
  • Access to information
  • Issues specific to paediatric trials
  • 16:20 ETHICAL ISSUES IN PAEDIATRIC CLINICAL TRIALS

    Karen Ruthven

    Karen Ruthven, European Operations Director, INTERCERN

  • Balancing the ethical difficulties in conducting trials in children
  • Role of research ethics committees
  • Placebo controlled studies
  • Directives and guidelines to help
  • 17:00 Chairman's Closing Remarks and Close of Conference

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    United Kingdom

    The Hatton, at etc. venues

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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